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NCT01520909 · OUTCOME

Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the WHO Bleeding Scale During Part 2

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Baseline of Part 2 through Follow-up

What was measured

The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO Grades were dichotomized into the following categories: no bleeding = Grade 0; any bleeding = Grade 1 to 4; no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4.

Analysis population: ITT Population. Only those participants who entered into Part 2 open-label Eltrombopag only phase were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Part 2 (Open-Label Period) - Eltrombopag

Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 2 (Open-Label Period) - Eltrombopag87

Reported measurements

Baseline, Any bleeding n=87
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag55Not reportedNot reportedNot reportedNot reported
Baseline, Significant bleeding n=87
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag17Not reportedNot reportedNot reportedNot reported
Week 1, Any bleeding n=86
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag29Not reportedNot reportedNot reportedNot reported
Week 1, Significant bleeding n=86
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Week 2, Any bleeding n=85
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag22Not reportedNot reportedNot reportedNot reported
Week 2, Significant bleeding n=85
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 3, Any bleeding n=86
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag20Not reportedNot reportedNot reportedNot reported
Week 3, Significant bleeding n=86
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Week 4, Any bleeding n=68
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag20Not reportedNot reportedNot reportedNot reported
Week 4, Significant bleeding n=68
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Week 5, Any bleeding n=61
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag21Not reportedNot reportedNot reportedNot reported
Week 5, Significant bleeding n=61
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Week 6, Any bleeding n=55
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag17Not reportedNot reportedNot reportedNot reported
Week 6, Significant bleeding n=55
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Week 7, Any bleeding n=52
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag14Not reportedNot reportedNot reportedNot reported
Week 7, Significant bleeding n=52
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Week 8, Any bleeding n=52
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag17Not reportedNot reportedNot reportedNot reported
Week 8, Significant bleeding n=52
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Week 9, Any bleeding n=45
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag11Not reportedNot reportedNot reportedNot reported
Week 9, Significant bleeding n=45
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Week 10, Any bleeding n=42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag8Not reportedNot reportedNot reportedNot reported
Week 10, Significant bleeding n=42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 11, Any bleeding n=40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag12Not reportedNot reportedNot reportedNot reported
Week 11, Significant bleeding n=40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Week 12, Any bleeding n=63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag15Not reportedNot reportedNot reportedNot reported
Week 12, Significant bleeding n=63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Week 13, Any bleeding n=30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag9Not reportedNot reportedNot reportedNot reported
Week 13, Significant bleeding n=30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 14, Any bleeding n=38
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag9Not reportedNot reportedNot reportedNot reported
Week 14, Significant bleeding n=38
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 15, Any bleeding n=43
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag10Not reportedNot reportedNot reportedNot reported
Week 15, Significant bleeding n=43
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 16, Any bleeding n=47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag11Not reportedNot reportedNot reportedNot reported
Week 16, Significant bleeding n=47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Week 17, Any bleeding n=37
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag10Not reportedNot reportedNot reportedNot reported
Week 17, Significant bleeding n=37
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 18, Any bleeding n=33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag8Not reportedNot reportedNot reportedNot reported
Week 18, Significant bleeding n=33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Week 19, Any bleeding n=44
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag15Not reportedNot reportedNot reportedNot reported
Week 19, Significant bleeding n=44
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 20, Any bleeding n=39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag7Not reportedNot reportedNot reportedNot reported
Week 20, Significant bleeding n=39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 21, Any bleeding n=41
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag10Not reportedNot reportedNot reportedNot reported
Week 21, Significant bleeding n=41
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 22, Any bleeding n=34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag7Not reportedNot reportedNot reportedNot reported
Week 22, Significant bleeding n=34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Week 23, Any bleeding n=36
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag15Not reportedNot reportedNot reportedNot reported
Week 23, Significant bleeding n=36
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Week 24, Any bleeding n=79
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag19Not reportedNot reportedNot reportedNot reported
Week 24, Significant bleeding n=79
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Follow-up Week 1, Any bleeding n=29
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag8Not reportedNot reportedNot reportedNot reported
Follow-up Week 1, Significant bleeding n=29
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Follow-up Week 2, Any bleeding n=37
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag25Not reportedNot reportedNot reportedNot reported
Follow-up Week 2, Significant bleeding n=37
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Follow-up Week 3, Any bleeding n=40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag17Not reportedNot reportedNot reportedNot reported
Follow-up Week 3, Significant bleeding n=40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Follow-up Week 4, Any bleeding n=70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag23Not reportedNot reportedNot reportedNot reported
Follow-up Week 4, Significant bleeding n=70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Any follow-up Week, Any bleeding n=77
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag38Not reportedNot reportedNot reportedNot reported
Any Follow-up Week, Significant bleeding n=77
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        55
    title
    Baseline, Any bleeding n=87
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Baseline, Significant bleeding n=87
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Week 1, Any bleeding n=86
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Week 1, Significant bleeding n=86
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Week 2, Any bleeding n=85
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Week 2, Significant bleeding n=85
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Week 3, Any bleeding n=86
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Week 3, Significant bleeding n=86
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Week 4, Any bleeding n=68
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Week 4, Significant bleeding n=68
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Week 5, Any bleeding n=61
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Week 5, Significant bleeding n=61
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO Grades were dichotomized into the following categories: no bleeding = Grade 0; any bleeding = Grade 1 to 4; no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4.
groups
  1. description
    Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
    id
    OG000
    title
    Part 2 (Open-Label Period) - Eltrombopag
param Type
NUMBER
population Description
ITT Population. Only those participants who entered into Part 2 open-label Eltrombopag only phase were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
reporting Status
POSTED
time Frame
From Baseline of Part 2 through Follow-up
title
Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the WHO Bleeding Scale During Part 2
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice